The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups

Depression Clinical Trial

Official title:

The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02538835
• Other study ID #: 46332
• Status: Not yet recruiting
• Phase: N/A
• First received: August 31, 2015
• Last updated: November 14, 2016
• Start date: August 2018

Study information

• Verified date: November 2016
• Source: University of Southern Denmark
• Contact: Mette E Andersen, PhD
• Phone: 65504625
• Email: melandersen[@]health.sdu.dk
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of metacognitive group therapy on depression compared to mindfulness groups and supportive groups. The participants, all with a history of depression and with current symptoms of depression, will be randomized to one of the three group interventions.

Description:

Metacognitive therapy (MCT) show promising results in alleviating depressive symptoms and reducing relapse of depression. However studies of MCT as a group intervention is limited and higher quality studies of the effectiveness of MCT is warranted. The present study aim to produce more conclusive evidence on the effect of MCT comparing MCT in groups with both and active control group and mindfulness based cognitive therapy (MBCT), which together with pharmacotherapy is currently one of the preferred treatment choices. Currently pharmacotherapy, cognitive therapy and MBCT seem to help 40-58% of the patients efficiently. The current studies of MCT indicate that this intervention may help a higher proportion of the patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Consent to participate

• History of clinical depression

• Current depressive symptoms

• Verbal and cognitive abilities to complete the questionnaires during the study

• Stable medication - if any medication is ordinated

• Speaks fluently danish

Exclusion Criteria:

• If criteria for psychosis, bipolar disorder or personality disorder is matched

• known brain damage or mental retardation

• substance abuse

• women who are pregnant or breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Metacognitive therapy
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.
• Mindfulness based cognitive therapy, group
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel & Segal.
• Support groups
Group format, 10-12 participants in each group. The sessions will only be of supportive character and will not focus on changing or restructuring thoughts, scripts or thought patterns. The format will follow a manual but compared to the other intervention groups the format allow participants to suggests themes for discussions.

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense	Southern Denmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Center for Kognitive Terapier og Supervision

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on Hamilton depression scale		8 weeks	No
Primary	Change from baseline on Hamilton depression scale		32 weeks	No
Secondary	Change from baseline on Becks depression inventory		8 weeks	No
Secondary	Change from baseline on Becks depression inventory		32 weeks	No
Secondary	Change from baseline on Becks Anxiety Inventory		8 weeks	No
Secondary	Change from baseline on Becks Anxiety Inventory		32 weeks	No
Secondary	Change from baseline on Ruminative Response Scale		8 weeks	No
Secondary	Change from baseline on Ruminative Response Scale		32 weeks	No
Secondary	Change from baseline on Metacognitive questionnaire		8 weeks	No
Secondary	Change from baseline on Metacognitive questionnaire		32 weeks	No